McNeil Recalls Motrin Drops After Plastic is Found in Ingredient - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

McNeil Recalls Motrin Drops After Plastic is Found in Ingredient


McNeil Consumer Healthcare Division of McNeil-PPC announced on Sept. 6 a voluntary recall at the retail level of three lots of Concentrated Motrin Infants’ Drops Original Berry Flavor (0.5 fl oz bottles) after 1 mm plastic particles were identified in a different product lot during manufacturing.  The lot in which the particles were discovered was not released to the market.

In a press statement posted on www.FDA.gov and the McNeil website, the company reported that the particles originated in a shipment from a third-party supplier of ibuprofen, the active ingredient in the recalled product.  The company said that, out of an abundance of caution, it was recalling the three lots—approximately 200,000 bottles distributed in the United States—that were made with the same batch of active ingredient.  

The company says it has worked with the third party to ensure that corrective measures are currently in place and the potential for adverse medical events related to the reason for this recall is not likely.   

McNeil is asking retailers to remove the affected lots from store shelves and is asking consumers to stop using and dispose of any product they may have that is included in this recall.

Sources: FDA and McNeil Consumer Healthcare Division of McNeil-PPC

 

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
30%
Attracting a skilled workforce
27%
Obtaining/maintaining adequate financing
14%
Regulatory compliance
30%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Obama Administration Halts Attack on Medicare Drug Plans

Click here